IRO Review of Additional Items Sample Clauses

IRO Review of Additional Items. As set forth in Section III.E.2.c of the CIA, for each Reporting Period, the OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”).
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IRO Review of Additional Items. As set forth in Section III.E.2 of the CIA, for each Reporting Period, OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). The Additional Items may include activities undertaken by Jazz in connection with Promotional Functions, as defined in Section II.C.3 of the CIA. For the second through fifth Reporting Periods, the Additional Items Review may include activities undertaken by Jazz in connection with any Pharmaceutical Manufacturer PAP, including the provision of free product to patients. No later than 150 days prior to the end of the applicable Reporting Period, OIG shall notify Jazz of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO and/or Jazz shall submit an audit work plan to OIG for approval. The IRO shall conduct the review of the Additional Items based on a work plan approved by OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IRO’s findings based on its review for each Additional Item; and the IRO’s recommendations for any changes in Jazz’s systems, processes, policies, and procedures based on its review of each Additional Item). Jazz may propose to OIG that relevant internal audit(s) or monitoring and/or other reviews conducted by outside entities at Jazz’s request be substituted for one or more of the Additional Item reviews that would otherwise be conducted by the IRO for the applicable Reporting Period. OIG retains sole discretion over whether, and in what manner, to allow Jazz’s internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the Additional Items review conducted by the IRO. In making its decision, OIG agrees to consider, among other factors, the nature and scope of Jazz’s planned monitoring activities and internal audit work, the results of the Transactions Review(s) during prior Reporting Period(s), and Jazz’s demonstrated audit capabilities to perform the proposed audit work internally. If OIG denies Jazz’s request to permit its internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Jazz shall engage the IRO to perform the Revie...
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IRO Review of Additional Items. ‌ As referenced in Section III.E.2 of the CIA, for the second through fifth Reporting Periods OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). Amgen has represented that, prior to the Effective Date of the CIA, Amgen established an annual external review process through which Amgen engages an outside entity to review and make findings regarding certain aspects of its operations (the “External Reviews”). For at least the second Reporting Period, OIG agrees to permit these External Reviews to be substituted for any Additional Items reviews by an IRO that would otherwise be required under this Section IV.B of Appendix B. At least 60 days prior to the end of the second Reporting Period, Amgen shall provide to OIG a list of all External Reviews completed in that Reporting Period. OIG may select up to three of the External Reviews and shall notify Amgen of its selection at least 30 days prior to the end of the second Reporting Period. For each External Review selected by the OIG, Amgen shall include the following information in its Annual Report for the second Reporting Period: (1) complete copies of any written reports produced as a result of the External Review, including any findings and recommendations; and (2) Amgen’s response and corrective action plan relating to any findings and recommendations set forth in the External Review report. For subsequent Reporting Periods, OIG shall retain sole discretion over whether to continue to permit Xxxxx’s External Reviews to be substituted for one or more of the Additional Item reviews that would otherwise by conducted by the IRO and to follow the process outlined above. If OIG determines it will not permit such substitution then, no later than 120 days prior to the end of the applicable Reporting Period, OIG shall notify Amgen of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO shall submit an audit work plan to OIG for approval. The IRO shall conduct the review of the Additional Items based on a work plan approved by OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IRO’s findings based on its review for each Additional Item; and the IRO’s recommendations for any changes in Amgen’s systems, processes, po...
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Related to IRO Review of Additional Items

  • Completion of Review for Certain Review Receivables Following the delivery of the list of the Review Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Review Receivable is paid in full by the Obligor or purchased from the Issuer in accordance with the terms of the Basic Documents. On receipt of such notice, the Asset Representations Reviewer will immediately terminate all Tests of the related Review Receivable, and the Review of such Review Receivables will be considered complete (a “Test Complete”). In this case, the related Review Report will indicate a Test Complete for such Review Receivable and the related reason.

  • ADB’s Review of Procurement Decisions 11. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan. SCHEDULE 5 Execution of Project and Operation of Project Facilities; Financial Matters

  • Claims Review Report The IRO shall prepare a Claims Review Report as described in this Appendix for each Claims Review performed. The following information shall be included in the Claims Review Report for each Discovery Sample and Full Sample (if applicable).

  • Claims Review Population A description of the Population subject to the Claims Review.

  • Claims Review Methodology a. C laims Review Population. A description of the Population subject to the Quarterly Claims Review.‌

  • Payment of Additional Costs If termination of this contract is due to the failure of the Engineer to fulfill its contract obligations, the State may take over the project and prosecute the work to completion, and the Engineer shall be liable to the State for any additional cost to the State.

  • AUDIT REVIEW PROCEDURES A. Any dispute concerning a question of fact arising under an interim or post audit of this AGREEMENT that is not disposed of by AGREEMENT, shall be reviewed by LOCAL AGENCY’S Chief Financial Officer.

  • CLAIMS FOR ADDITIONAL COST 12.3.1 If the Contractor wishes to make a claim for an increase in the Contract Sum, he shall give the Architect written notice thereof within twenty days after the occurrence of the event giving rise to such claim. This notice shall be given by the Contractor before proceeding to execute the Work, except in an emergency endangering life or property in which case the Contractor shall proceed in accordance with Paragraph 10.3 of these General Conditions. No such claim shall be valid unless so made. If the State and the Contractor cannot agree on the amount of the adjustment in the Contract Sum, it shall be determined by the Architect. Any change in the Contract Sum resulting from such claim shall be authorized by Change Order.

  • Completion of Review for Certain Subject Receivables Following the delivery of the list of the Subject Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Subject Receivable is paid in full by or on behalf of the Obligor or purchased from the Issuer by the Sponsor or the Servicer in accordance with the Transaction Documents. On receipt of notice, the Asset Representations Reviewer will immediately terminate all Tests of such Receivables and the Asset Review of such Receivables will be considered complete (a “Test Complete”). In this case, the Review Report will indicate a Test Complete for the Receivables and the related reason.

  • Review Protocol A narrative description of how the Claims Review was conducted and what was evaluated.

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